BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2200096 · Received August 10, 2011

    Report

    Report Number
    1823260-2011-04313
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 27, 2011
    Report Date
    October 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE EVENT DETERMINED THE ISE SIPPER PROBE WAS PARTIALLY BLOCKED DUE TO A LACK OF SYSTEM MAINTENANCE BY THE CUSTOMER. IT WAS ALSO NOTED THE USER RAN THE SAMPLES AFTER A FAILED CALIBRATION. THE EVENT DID NOT CAUSE OR CONTRIBUTE TO INJURY, ILLNESS OR DETERIORATION IN HEALTH OF A PATIENT.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) RESULTS FOR THREE PATIENT SAMPLES FROM THE COBAS C501 ANALYZER. OF THE DATA PROVIDED, ONLY THE RESULTS FOR ONE PATIENT SAMPLE WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL SODIUM RESULT WAS 124 MMOL/L, THE REPEAT RESULT ON (B)(6) 2011 WAS 141 MMOL/L AND THE REPEAT RESULT ON (B)(6) 2011 WAS 141 MMOL/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY, BUT THE USER CONTACT THE DOCTOR IN THE ER AND LET HIM KNOW THE RESULTS REPORTED MAY NOT BE CORRECT. THE RESULTS FROM (B)(6) 2011 WERE SENT AS A CORRECT REPORT. THE PATIENT WAS NOT TREATED BASED ON THE ERRONEOUS RESULTS. THE SODIUM ELECTRODE LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PARTIAL BLOCKAGE IN THE ISE SIPPER PROBE AND HE REPLACED THE PROBE AND TUBING. HE VERIFIED THE ANALYZER OPERATION BY RUNNING PERFORMANCE TESTING, ISE CALIBRATIONS AND QUALITY CONTROL WITH ALL RESULTS MEETING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER CEM ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1